Betamethasone-darnitsa
Ukraine
Table of Contents
INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT BETAMETHASONE-DARNITSA (Betamethasone-Darnitsa)
Composition:
Active substances: betamethasone, cetylpyridinium;
1 g of cream contains: betamethasone valerate 1.22 mg, cetylpyridinium chloride 4 mg;
Excipients: propylene glycol, mineral oil, cetylstearyl alcohol, disodium edetate, purified water.
Pharmaceutical form. Cream.
Main physico-chemical characteristics: homogeneous white odourless cream.
Pharmacotherapeutic group. Corticosteroids in combination with antiseptics. Betamethasone and antiseptics. ATC code D07BC01.
Pharmacological properties.
Betamethasone valerate, included in the medicinal product, exerts local anti-inflammatory, antiallergic, antipruritic, and anti-exudative effects.
Cetylpyridinium chloride exerts bacteriostatic and fungistatic action, thus preventing the development of secondary infection.
Clinical characteristics.
Indications.
Reduction of inflammatory manifestations of dermatoses sensitive to glucocorticosteroid therapy, such as: eczema (atopic, nummular), neurodermatitis, dermatitis (contact, solar, seborrheic, exfoliative, radiation, intertriginous, stasis dermatitis), psoriasis (except generalized psoriasis), anogenital and senile pruritus.
Contraindications.
Hypersensitivity to the active substances or to any of the excipients of the medicinal product; bacterial, viral (including herpes simplex, herpes zoster, varicella, tuberculosis and syphilis of the skin), fungal skin infections, post-vaccination skin reactions, rosacea, rosacea-like (perioral) dermatitis, first trimester of pregnancy.
The medicinal product is not intended for ophthalmic use.
Interaction with other medicinal products and other forms of interaction.
The medicinal product is not recommended to be used concomitantly with topical medicinal products, particularly those containing anionic surfactants, which may inactivate the action of cetylpyridinium chloride.
Vaccination against smallpox should not be performed during treatment, and other types of immunization should also be avoided (especially during prolonged use over large areas of skin) due to the possible lack of an adequate immunological response, such as production of specific antibodies.
The medicinal product may enhance the effect of immunosuppressive agents and reduce the effect of immunostimulatory medicinal products.
Due to the presence of mineral oil as an excipient, application of the medicinal product in the anogenital area may damage the structure of latex condoms and reduce their safety when used.
In cases where systemic absorption of betamethasone can be anticipated, numerous interactions with other medicinal products should be taken into account.
Special precautions for use.
The medicinal product is not intended for ophthalmological use (in the eyes, around the eyes).
Caution should be exercised when applying the medicinal product near the face, and contact with the eyes and mucous membranes should be avoided, as this may lead to the development of glaucoma or cataract.
If symptoms such as blurred vision or other visual disturbances occur, patients should consult an ophthalmologist to evaluate possible causes, including cataract, glaucoma, or rare conditions such as central serous chorioretinopathy, which has been reported with systemic and topical corticosteroid use.
The medicinal product should not be applied to the facial skin due to the risk of adverse effects (telangiectasia, perioral dermatitis), even after short-term use.
If infection is present, appropriate antifungal or antibacterial agents should be administered.
The medicinal product should be used with caution in patients with psoriasis, as topical application of glucocorticosteroids to psoriatic lesions may lead to exacerbation of the disease due to development of tachyphylaxis, generalized pustular psoriasis, or systemic toxicity resulting from impaired skin barrier function.
The medicinal product is not recommended for use under occlusive dressings, over large skin areas (high doses), and/or for prolonged periods (more than 3–4 weeks) due to systemic absorption of betamethasone.
Systemic absorption of topical corticosteroids increases with higher doses. Highly potent corticosteroids applied over large skin areas should be used under strict medical supervision with periodic patient monitoring, as they may suppress the hypothalamic-pituitary-adrenal (HPA) axis. HPA axis function usually recovers after discontinuation of the medicinal product. In some cases, withdrawal symptoms may develop, requiring supplementation with systemic corticosteroids. If HPA axis suppression occurs, the frequency of application should be reduced or treatment discontinued, and the patient should be switched to a less potent corticosteroid.
If fungal or bacterial superinfection of the skin develops, concomitant antifungal or antibacterial therapy is required. If the desired effect is not rapidly achieved, corticosteroid use should be discontinued until signs of infection resolve.
Use in the groin and genital areas should be limited to cases of exceptional necessity, as increased absorption and adverse effects may occur even after short-term application.
The medicinal product should be used with caution in patients with pre-existing atrophic subcutaneous tissue conditions, particularly in elderly individuals.
Avoid using the medicinal product over large skin areas, on damaged skin, in high doses, and in patients with renal or hepatic impairment, as well as in children.
Excipients.
This medicinal product contains propylene glycol, which may cause skin irritation.
This medicinal product contains cetyl stearyl alcohol, which may cause local skin reactions (e.g., contact dermatitis).
If skin irritation or signs of hypersensitivity occur, use of the medicinal product should be discontinued and medical advice should be sought.
Use during pregnancy or breastfeeding.
Pregnancy
The medicinal product should not be used during the first trimester of pregnancy.
There are insufficient data on the use of this medicinal product in pregnant women. Reproductive toxicity has been observed in animal studies with betamethasone valerate.
The medicinal product may be prescribed only during later stages of pregnancy and only if the expected benefit to the mother clearly outweighs the potential risk to the fetus. Medicinal products of this class should not be used in high doses, for prolonged periods, or under occlusive dressings during pregnancy.
Breastfeeding
It is currently unknown whether topical corticosteroids, due to systemic absorption, can pass into breast milk. Therefore, during breastfeeding, avoid using the medicinal product over large skin areas or for prolonged periods. When deciding whether to discontinue breastfeeding or discontinue use of the medicinal product, the importance of the therapy for the mother should be considered. Contact between the infant and treated areas of the mother's skin should be avoided.
Ability to affect reaction speed when driving or operating machinery.
Generally, the medicinal product does not affect the patient's reaction speed when driving or operating machinery.
Method of Administration and Dosage
The medicinal product is intended for topical use. Apply the cream as a thin layer to the affected skin area 1–3 times daily, depending on the severity of the condition. The frequency of application depends on the extent of the lesion: for mild cases, the medicinal product may be applied once daily; for more severe cases, the frequency of application should be increased. In most cases, applying the medicinal product 1–2 times daily is sufficient to achieve the desired effect.
Do not use the medicinal product under occlusive dressings, as this may enhance adverse effects.
Continuous use of the medicinal product should not exceed 4 weeks. If the patient's condition does not improve or worsens within 2–4 weeks of therapy, a reassessment should be performed and the treatment regimen reviewed.
Careful monitoring for signs and symptoms of systemic effects of the medicinal product is recommended.
Specific antibacterial therapy should be used in dermatoses associated with bacterial infection.
Patients with fungal dermatoses require specific antifungal treatment.
Children
The safety of the medicinal product in children has not been established; therefore, the product is not recommended for use in this patient population.
Since children have a higher surface area-to-body weight ratio compared to adults, and thus more active absorption of the medicinal product, they are at greater risk of hypothalamic-pituitary-adrenal (HPA) axis suppression and the development of exogenous corticosteroid effects.
Overdose
Symptoms: Excessive or prolonged use of topical corticosteroids may lead to suppression of pituitary-adrenal function, resulting in secondary adrenal insufficiency and symptoms of hypercorticism, including Cushing's syndrome. Acute symptoms of hypercorticism are usually reversible.
Treatment: Symptomatic therapy; if necessary, correction of electrolyte imbalance. In cases of chronic toxic effects, gradual withdrawal of the medicinal product is recommended.
Adverse Reactions
Below are the adverse reactions associated with the topical use of corticosteroids.
The frequency of adverse effects is classified as follows: very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1,000 to < 1/100); rare (≥ 1/10,000 to < 1/1,000); very rare (< 1/10,000); frequency not known (frequency cannot be estimated based on available data).
Eye disorders: frequency not known – blurred vision, development of glaucoma or accelerated progression of cataract have been reported with topical application of corticosteroids to the eyelid skin.
Endocrine system disorders: frequency not known – suppression of the hypothalamic-pituitary-adrenal (HPA) axis leading to secondary adrenal insufficiency, symptoms of hypercorticism, Cushing's syndrome.
Any adverse effects observed with systemic administration of glucocorticosteroids, including suppression of adrenal cortex function, may also occur with their topical use, especially when used in high doses for prolonged periods or under occlusive dressings.
In children receiving topical corticosteroids, cases of adrenal cortex suppression, Cushing's syndrome, growth retardation, failure to gain weight, and intracranial hypertension have been reported. Signs of adrenal suppression in children include low plasma and urinary cortisol levels and lack of response to adrenocorticotropic hormone stimulation. Manifestations of intracranial hypertension include bulging fontanelle, headache, and bilateral optic disc swelling.
Immune system disorders: frequency not known – hypersensitivity reactions, including urticaria, maculopapular rash.
Skin and subcutaneous tissue disorders: common – burning sensation, pruritus, irritation, dryness, folliculitis, hypertrichosis, acneiform eruptions, hypopigmentation, steroid-induced acne, rosacea-like (perioral) dermatitis, allergic contact dermatitis; uncommon – skin maceration, skin atrophy, striae, miliaria, particularly under occlusive dressing; frequency not known – skin tingling, skin induration, skin cracking, sensation of warmth, lamellar desquamation, focal desquamation, follicular rash, erythema, telangiectasia, skin thickening.
Prolonged continuous use may lead to skin atrophy, striae, and telangiectasia, particularly when applied to the face.
Infections and infestations: uncommon – secondary infection, especially under occlusive dressing.
Shelf life. 2 years.
Storage conditions.
Store in the original packaging at a temperature not exceeding 25 °C.
Keep out of reach of children.
Packaging.
15 g or 30 g in a tube; 1 tube in a carton.
Prescription category. Prescription only.
Manufacturer. JSC "Pharmaceutical Company "Darnytsia".
Manufacturer's address and place of business.
13, Boryspylska Street, Kyiv, 02093, Ukraine.